Detection of influenza A and B with the Alere™ i Influenza A & B: a novel isothermal nucleic acid amplification assay

Influenza and Other Respiratory Viruses

Briony Hazelton¹  Timothy Gray¹  Jennifer Ho¹  V. Mala Ratnamohan¹  Dominic E. Dwyer¹ 

[1] Centre for Infectious Diseases and Microbiology Laboratory Services, Institute for Clinical Pathology and Medical Research, Westmead Hospital, Westmead, NSW, Australia

关键词: Influenza;    isothermal nucleic acid amplification;    rapid diagnostic test(s);    sensitivity;    specificity;   

DOI  :  10.1111/irv.12303

来源: Wiley

【 摘 要 】

Abstract

Background

Rapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; however, the performances of currently available assays vary widely.

Objectives

We evaluated the performance of the Alere^™ i Influenza A&B (Alere^™ iNAT), a rapid isothermal nucleic acid amplification assay that has recently received FDA clearance, for the detection of influenza A and B viruses during the Australian influenza season of 2013. Results were compared to two other RIDTs tested in parallel; Quidel Sofia^® Influenza A+B fluorescent immunoassay (FIA) and Alere^™ BinaxNOW^® Influenza A & B immunochromatographic (ICT) assay.

Methods

A total of 202 paired nasopharyngeal swabs collected from patients ≥16 years old with an influenza-like illness (ILI) were eluted in 2 ml of universal transport medium (UTM) that was used to perform all three RIDTs in parallel. Reverse-transcription polymerase chain reaction (RT-PCR) was used as the reference standard.

Results

Compared to RT-PCR, Alere^™ iNAT detected 77·8% influenza A positive samples versus 71·4% and 44·4% for the Quidel Sofia^® Influenza A+B FIA and BinaxNOW^® Influenza A & B ICT assay, respectively. For influenza B, Alere^™ iNAT detected 75% of those positive by RT-PCR, versus 33·3% and 25·0% for Sofia^® and BinaxNOW^®, respectively. The specificity of Alere^™ iNAT was 100% for influenza A and 99% for influenza B.

Conclusions

Alere^™ i Influenza A&B is a promising new rapid influenza diagnostic assay with potential point-of-care applications.

【 授权许可】

CC BY   
© 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.